Safety and Tolerability of hCBE-11 in Subjects With Advanced Solid Tumors
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This is a Phase I, open-label, dose-escalation study on subjects with advanced solid tumors. This is the first study of hCBE-11 in humans and is designed to determine the safety and how well patients tolerate this investigational drug. The study duration is two years with treatment visits occurring weekly for either 4 or 8 weeks, follow-up for 8 weeks and long-term follow-up contact every 3 months thereafter.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Relapsed or refractory solid tumors not curable with standard therapy.
At least one measurable lesion
ECOG Performance Status less than or equal to 2
Acceptable hematologic status
Albumin greater than or equal to 2.5 g/dL
Normal calculated glomerular filtration rate (GFR)
Acceptable liver function
Uncontrolled cardiac disease, angina, congestive heart failure, or myocardial infarction within 6 months prior to Study Day
Known history of hepatitis B or C, or HIV infection
Clinically significant effusions, including pericardial, pleural, and ascites
Serious non-malignant disease
Central nervous system (CNS) metastatic involvement except where the disease has been successfully treated
Investigational therapies within 4 weeks of Study Day 1
Radiation therapy of tumors to be followed for this study
Chemotherapy, biologic therapy, or major surgery other than diagnostic within 4 weeks prior to Study Day 1